Cyclopentanol, 2-pentyl-, (1R,2S)-rel-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 11 to April 03, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OECD test Guideline No. 423 without any deviation.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

(inspected on April 22, 25-29, 2005; May 09-13, 2005 / signed on November 2005)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

cis-2- Pentylcyclopentanol

Cas Number:

157357-30-7

Molecular formula:

C10H20O

IUPAC Name:

cis-2- Pentylcyclopentanol

Test material form:

other: liquid

Details on test material:

- Physical state: colourless liquid
- Stability: stable under storage conditions. Stability is unknown in PEG 300.
- Storage conditions: in the refrigerator (range of 5±3°C), light protected and under nitrogen gas.

Test animals

Species:

rat

Strain:

other: HanRcc:WIST (SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Wölferstrasse 4, 4414 Füllinsdorf, Switzerland.
- Age at study initiation: 11 weeks
- Weight at study initiation: 185-207 g
- Housing: in groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding.
- Fasting period before study: 16.5 to 18 hours (access to water was permitted). Food was provided again approximately 4 hours after dosing.
- Diet: pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no 77/07 (Provini Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum. Not contaminated.
- Water: community tap water from Füllinsdorf ad libitum. Not contaminated.
- Acclimation: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 2008-03-11 to 2008-04-03

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE: PEG 300
- Concentration in vehicle: : 0.2 g/mL
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation.
- Lot/batch no. (if required): 1310049
- Source: FLUKA Chemie GmbH, CH-9471 Buchs.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 groups, each of 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 day
- Clinical signs: 30 minutes, 1, 2, 3 and 5 hours after treatment on Day 1 and once daily during test days 2-15.
- Mortality/viability: 30 minutes, 1, 2, 3 and 5 hours after treatment on Day 1 and twice daily during test days 2-15.
- Frequency of weighing: recorded on Day 1(just prior to administration) and on day 8 and 15.
- Necropsy of survivors performed: yes, macroscopic examination. No organ or tissues were retained.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Shortly after dosing or at the 1-hour observation, a slight sedation was recorded in the 6 females which persisted up to the 5-hour observation. In 2 females, the sedation progressed into moderate at the 5-hour reading. Additionally, 5 females were found

Gross pathology:

No macroscopic findings were recorded at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Oral LD50 (Female rat) > 2000 mg/kg bw

Executive summary:

In a limit acute oral toxicity study performed according to the OECD test guideline No. 423 and in compliance with GLP, two groups, each of three fasted female HanRcc:WIST (SPF) rats were treated with a single oral gavage administration of 2000 mg/kg bw. The test material was diluted in PEG 300 at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.

 

No deaths occurred during the study.

Shortly after dosing or at the 1-hour observation, a slight sedation was recorded in the 6 females which persisted up to the 5-hour observation. In 2 females, the sedation progressed into moderate at the 5-hour reading. Additionally, 5 females were found to express a slightly poor coordination 20 minutes post-dose, or at the 1- or 5 hour reading. This symptom persisted up to the 1-, 2-, 3- or 5-hour reading. Furthermore, 5 females were found with a slightly ruffled fur shortly after treatment or at the 1-hour evaluation which persisted up to the 5-hour evaluation. Otherwise, no clinical signs were observed in any animal at any observation.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were recorded at necropsy.

 

Oral LD50 (Female rat) > 2000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.